The effect of local anaesthesia on postoperative pain and hemostasis after dental rehabilitation under general anaesthesia in pediatric patients
| ISRCTN | ISRCTN18557910 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18557910 |
- Submission date
- 31/12/2022
- Registration date
- 08/01/2023
- Last edited
- 12/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Dental caries, also known as tooth decay, is a common disease that affects children. It has multiple causes and its treatment can be challenging, especially when the child is uncooperative. In such cases, dental treatment under general anaesthesia may be used. However, the use of local anaesthesia as an alternative is a controversial issue. The aim of the study is to investigate the effects of using local anaesthesia on post-operative pain and bleeding after dental treatment under general anaesthesia in children.
This research aims to study the effect of local anaesthesia on postoperative pain and hemostasis after Dental rehabilitation under general anaesthesia.
Who can participate?
Children of both genders aged three to seven years, described by Frankel’s behavior rating scale as definitely negative.
What does the study involve?
The usage or not of local anaesthesia agents when treating children under general anaesthesia.
What are the possible benefits and risks of participating?
One of the benefits is the reduction in both pain and bleeding post-operatively as mentioned in some studies.
The risk of using local anaesthesia when treating children under general anaesthesia is an overdose of the used agent and the interaction with general anaesthesia agents.
Where is the study run from?
Al Bashir hospital (Jordan)
When is the study starting and how long is it expected to run for?
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Amal Batarseh, amal_batarseh@yahoo.com
Contact information
Scientific
ALhashimi Alshamaly
Basman Erea
Hay Naifah
Next to Prince Hamazah Hospital
P.O.Box: 86
Amman
11118
Jordan
 ORCID ID |
0000-0002-1218-3858 |
|---|---|
| Phone | +962 5200230 |
| amal_batarseh@yahoo.com |
Study information
| Study design | Single-arm parallel-design single-blinded randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 42974 PIS.pdf |
| Scientific title | The effect of local anaesthesia on postoperative pain and hemostasis after dental rehabilitation under general anaesthesia in pediatric patients aged from three to seven years old |
| Study objectives | Local anaesthesia effects on postoperative pain and hemostasis |
| Ethics approval(s) | Approved 20/02/2020, Scientific Research Ethics Committee (Ministry of Health, ALhashimi Alshamaly, Basman Erea, Hay Naifah, Next to Prince Hamazah Hospital, P.O.Box: 86, Amman, Jordan; +9625200230; no email provided), ref: Moh/REC/2020/44 |
| Health condition(s) or problem(s) studied | Post operative pain following dental treatment under general anaesthesia |
| Intervention | Forty-six boys and girls were included in this single-arm, parallel-design, single-blinded, randomized, controlled study. Before the commencement of the study, numbers from one to forty-six were randomly assigned as with local anaesthesia (LA) or without LA in closed envelope. Group A: given LA which is (2% weight/volume (w/v) lidocaine with 1:80000 epinephrine) by calculating the dose according to the provided formula not exceeding 4.4 mg/kg. Group B: not given any extra medication |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain measured using: 1. Universal-pain-assessment-tool (UPAT) before the operation 2. FLACC behavior scale immediately after treatment, 30 min and 6 hours |
| Secondary outcome measures | Hemostasis measured using bleeding score obtained immediately after extraction using the Boezaart-surgical-field-grading-scale. |
| Overall study start date | 15/01/2020 |
| Completion date | 01/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 7 Years |
| Sex | Both |
| Target number of participants | 46 |
| Total final enrolment | 43 |
| Key inclusion criteria | 1. Aged three to seven years 2. Described by Frankel’s behavior rating scale as definitely negative. 3. Arabic-speaking and healthy, with an American Society of Anesthesiologists (ASA) I or II classification |
| Key exclusion criteria | 1. Needing treatment or extraction of permanent teeth 2. Having an either medical, mental, or physical impairment 3. Need only restorative treatment without extraction or vice versa |
| Date of first enrolment | 01/03/2020 |
| Date of final enrolment | 01/03/2022 |
Locations
Countries of recruitment
- Jordan
Study participating centre
-
Jordan
Sponsor information
Government
ALhashimi Alshamaly
Basman Erea
Hay Naifah
Next to Prince Hamazah Hospital
P.O.Box: 86
Amman
11118
Jordan
| Phone | +962 65200230 |
|---|---|
| diwan@moh.gov.jo | |
| Website | https://www.moh.gov.jo/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. amal_batarseh@yahoo.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/01/2023 | No | Yes | ||
| Other unpublished results | 13/02/2023 | No | No | ||
| Other unpublished results | Participant flow diagram | 13/02/2023 | No | No | |
| Results article | 27/11/2023 | 12/03/2025 | Yes | No |
Additional files
- 42974 PIS.pdf
- 42974 Results Report.pdf
- 42974 Participant flow diagram.pdf
- Participant flow diagram
Editorial Notes
12/03/2025: Publication reference added.
NHW 20/02/2023: Internal review.
13/02/2023: A results report and participant flow diagram (unpublished) was added.
04/01/2023: Trial's existence confirmed by Ministry of Health, Jordan.
